Kornimate/medical-research-clean huggingface dataset:
safety and efficacy study of stem cell transplantation to treat dilated cardiomyopathy

Conditions: Dilated Cardiomyopathy

Summary: several studies have documented that transplantation of bone marrow-derived cells (bmc) following acute myocardial infarction is associated with a reduction in infarct scar size and improvements in left ventricular function and perfusion. the available evidence in humans suggests that bmc transplantation is associated with improvements in physiologic and anatomic parameters in both acute myocardial infarction and chronic ischemic heart disease, above and beyond the conventional therapy. in particular, intracoronary application of bmc is proved to be safe and was associated with significant improvement in the left ventricular ejection fraction (lvef) in patients with chronic heart failure. in contrast to ischemic heart failure, the data on effects of bmc transplantation in patients with dilated cardiomyopathy are limited to pre-clinical studies. in a rat model of dilated cardiomyopathy, intramyocardial delivery of pluripotent mesenchymal cells improved lvef, possibly through induction of myogenesis and angiogenesis, as well as by inhibition of myocardial fibrosis, suggesting that the beneficial effects of stem cell transplantation in dilated cardiomyopathy may primarily be related to their ability to supply large amounts of angiogenic, antiapoptotic, and mitogenic factors. similarly, transplantation of cocultured mesenchymal stem cells and skeletal myoblasts was shown to improve lvef in a murine model of chagas disease. study aim: to define the clinical effects of bmc transplantation in dilated cardiomyopathy in a pilot clinical study investigating the effects of intracoronary cd34+ cell transplantation on functional, structural, neurohormonal, and electrophysiologic parameters in patients with end-stage dilated cardiomyopathy.

patients were randomly allocated in a 1:1 ratio to receive intracoronary transplantation of autologous cd34+ stem cells (sc group) or no intracoronary infusion (control group). at the time of enrollment, and at yearly intervals thereafter, we performed detailed clinical evaluation, echocardiography, 6-minute walk test, and measured plasma levels of nt-probnp. to better-define the potential role of inflammatory response, we also measured plasma inflammatory markers (tumor necrosis factor \[tnf\]-α and interleukin \[il\]-6) at the time of cd34+ stem cell injection.

Eligibility criteria:
inclusion criteria: * normal coronary angiogram * left ventricular ejection fraction \< 40% * nyha iii or iv heart failure symptoms * bone marrow reactivity (g-csf test) * presence of viable myocardium exclusion criteria: * hematologic malignancy * multiorgan failure

Keywords: stem cells heart failure dilated cardiomyopathy
the glycemic response elicited by beta-glucans of different physical properties and form

Conditions: Type 2 Diabetes

Summary: the ability of oat β-glucan to lower postprandial glycemic responses has been attributed to the viscosity of the solution in which the fibre is solubilized. to our knowledge, no studies have investigated the effect of β-glucan solutions on glycemic response when concentration, and thus viscosity, is varied by changing the solution volume but not the β-glucan dose. therefore, the investigators will test the effects of altering β-glucan solution viscosity by altering solution volume at a fixed amount of β-glucan fibre.

the ability of β-glucan to lower postprandial glycemic responses has been attributed to the viscosity of the solution in which the fibre is solubilized. it has been demonstrated that the viscosity of a β-glucan solution increases with the molecular weight (mw) of β-glucan polymers, as well as the dose or concentration (c) of those polymers in solution. numerous studies have shown that glycemic response-lowering is strengthened when the c of a β-glucan solution of fixed liquid volume is increased by increasing β-glucan dose. however, the c of a β-glucan solution depends on not only the amount of fibre present but also on the solution volume. to our knowledge, no studies have investigated the effect of β-glucan solutions on glycemic response when c, and thus viscosity, is varied by changing the solution volume but not the β-glucan dose. therefore, the investigators will test the effects of altering β-glucan solution viscosity by altering solution volume at a fixed amount of β-glucan fibre. knowing how to incorporate β-glucan into solution so that its physiological benefits are preserved will assist in the development of β-glucan-containing functional foods.

Eligibility criteria:
inclusion criteria: * healthy men and women exclusion criteria: * bmi greater than or equal to 35 * known to have diabetes, hiv, hepatitis or a heart condition * use of medications or having a condition which may harm the subjects * use of medication which may affect the study results

Keywords: postprandial blood glucose dietary fiber beta-glucan
engaging clinical champions to improve hpv vaccination

Conditions: Human Papilloma Virus

Summary: this trial will compare two ways to improve communication about hpv vaccination in primary care. the research team will work with primary care clinics. some clinics will receive communication training from an outside expert. other clinics will receive the same training from a vaccine champion from their healthcare system.

the researchers will conduct a cluster randomized non-inferiority trial. the trial will compare two ways of delivering a communication workshop called announcement approach training (aat). aat is designed to improve communication about hpv vaccination in primary care. the researchers will randomize clinics within participating healthcare systems. some clinics will receive the training from an outside expert. other clinics will receive the same training from a vaccine champion from their own system. the researchers will use medical record data to compare changes in hpv vaccination among children ages 9-12. clinics will be followed for 12 months. the study will engage clinical staff. researchers will not have direct contact with children or their families.

Eligibility criteria:
this trial will enroll clinics and intervene with clinical staff. we will use vaccination data from children to evaluate intervention effectiveness. we will not enroll children or interact with them directly. inclusion criteria clinics are eligible if they: * provide primary care to children ages 9-12 * specialize in pediatrics or family medicine children's medical records will be eligible to be included in the dataset if children: * are between the ages of 9-12 years at baseline * are attributed to a participating clinic at 12-month follow-up exclusion criteria clinics are excluded if they: * do not provide primary care to children ages 9-12 * have a specialty other than pediatrics or family medicine children's medical records will be excluded if children: * are not between the ages of 9-12 years at baseline * are not attributed to a participating clinic at 12-month follow-up * are receiving hospice/palliative care, are pregnant, or have a history of hpv vaccine contraindications

Keywords: human papilloma virus vaccination adolescent medicine primary care clinical champions
the impact of antibiotic prophylaxis on incidence of post-bronchoscopy fever and change of serum cytokines

Conditions: Fever; Pneumonia

Summary: fever can develop after fiberoptic bronchoscopy (fb) in about 2.5 - 16 % of adult patients. we evaluated the impact of oral amoxicillin/clavulanate (ac) on incidence of postbronchoscopic fever and pneumonia.

for the population being undergone with bronchoscopy, the clinical signs and procedural measures for complication of bronchoscopy and cytokines will be checked.

Eligibility criteria:
inclusion criteria: * adult patients (aged 18 years or older) who underwent fb exclusion criteria: * concurrent treatment with antibiotics or systemic corticosteroid

Keywords: bronchoscopy post-bronchoscopy fever pneumonia cytokines amoxicillin/clavulanate prophylaxis
pharmacokinetic characteristics, safety, tolerability and immunogenicity of ly01008 and avastin in healthy chinese male subjects

Conditions: Metastatic Colorectal Cancer; Non Small Cell Lung Cancer Metastatic; Non Small Cell Lung Cancer Recurrent

Summary: this is a randomized, double-blind, single-dose, parallel-group study comparing pharmacokinetic characteristics, safety , tolerability and immunogenicity of ly01008 (recombinant humanized anti-human vascular endothelial growth factor monoclonal antibody injection) and avastin (bevacizumab injection) in healthy chinese male subjects.


Eligibility criteria:
inclusion criteria: * healthy male volunteers * subjects aged 18 - 45 years * subjects weighing ≥ 50.0 kg and ≤ 100.0 kg * subjects with a body mass index (bmi) ≥ 19.0 and ≤ 26.0 kg/m2 exclusion criteria: * subjects with evidence or history of clinically significant disease * subjects with a history of previous cancer * subjects with a history of hypertension, or abnormal blood pressure at screening/baseline measurements (systolic blood pressure \> 140 mmhg and/or diastolic blood pressure \> 90 mmhg confirmed by a repeat measurement on the same day) * subjects with a history of blood donation 3 months before study drug infusion * subjects with a history of exposure to antibodies 12 months before study drug infusion * subjects with previous exposure to anti-vegf therapy
liquid biopsy in monitoring the therapeutic efficacy of targeted therapy in advanced/metastatic gastric cancer

Conditions: Gastric Cancer

Summary: to evaluate the clinical significance of cell free dna (cfdna) and circulating tumor cells (ctcs) in real-time monitoring the therapeutic response during her2-targeted therapy in histologically confirmed her2 positive advanced/metastatic gastric cancer.

the study is a single-center, prospective study undertaken in anticipated 124 patients with both histologically her2 positive and negative advanced/metastatic gastric cancer. peripheral blood samples of 12.5 ml were collected from the patients for cfdna and ctcs analysis. the blood samples will be respectively drawn before therapy, at the time that the patients achieve the optimal response and when they suffer progressive disease. the enumeration of ctcs as well as the detection of her2 expression will be achieved via the integrated subtraction enrichment (set) and immunostaining-fluorescence in situ hybridization (ifish) platform. further, for the geneomic analysis, the enriched single ctc will be isolated for single-cell targeted sequencing. while for cfdna analysis, extracted dna from plasma will be directly subjected to targeted sequencing. the correlation of the her2 status on ctcs and the her2 amplification in cfdna to the therapeutic response will be evaluated. moreover, gene variations associated with resistance in her2-targeted therapy will be also studied based on the genomic data from sequencing of ctc and cfdna.

Eligibility criteria:
inclusion criteria: * having signed informed consent * age≥ 18 years old * histologically confirmed her2 positive gastric adenocarcinoma * unresectable recurrent or metastatic disease * measurable disease according to the recist criteria * karnofsky performance status ≥60 * life expectancy of ≥2 month * alt and ast\<2.5 times uln (≤5 times uln in patients with liver metastases) * serum albumin level ≥3.0g/dl * serum akp \< 2.5 times uln * serum creatinine \<uln, and ccr \< 60ml/min * bilirubin level \< 1.5 uln * wbc\>3,000/mm3, absolute neutrophil count ≥2000/mm3, platelet\>100,000/mm3, hb\>9g/dl exclusion criteria: * brain metastasis (known or suspected) * surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry. contraindications of nuclear magnetic resonance image such as fitment of cardiac pacemaker , nerve stimulator, or aneurysm clip, and metallic foreign body in eye ball and so on. * allergic constitution or allergic history to protium biologic product or any investigating agents. * severe heart disease or such history as recorded congestive heart failure, uncontrolled cardiac arrhythmia, angina pectoris needing medication, cardiac valve disease, severe abnormal ecg findings, cardiac infarction , or retractable hypertension. * pregnancy or lactation period * other previous malignancy within 5 year, except non-melanoma skin cancer * pre-existing neuropathy\>grade 1 * legal incapacity

Keywords: cell free dna circulating tumor cell therapeutic efficacy
a study to determine the safety and effectiveness of rad001 (everolimus) in patients with lymphangioleiomyomatosis

Conditions: Lymphangioleiomyomatosis

Summary: this was an exploratory study to determine whether escalating doses of rad001 (everolimus) were safe and effective in patients with lymphangioleiomyomatosis

in addition to the data collected in this study, historical data from 43 patients treated with placebo from the multicenter trial of sirolimus in lam (miles) study (nct00414648) were down weighted to an effective sample size of 18 for comparison of fev1 and fvc endpoints. reference to the publication of the miles study has been provided under "result publication".

Eligibility criteria:
inclusion criteria: * female aged \>/= 18 years with a diagnosis of lam * pulmonary function abnormalities as follows: * fev1 of ≤ 80% of the predicted value following administration of a standard dose of a short acting β2-agonist (\*200 µg salbutamol, measured between 10 and 15 minutes of inhalation) or * fev1 \< 90% of the predicted value of bronchodilator following administration of a standard dose of a short acting β2-agonist (\*200 µg salbutamol, measured between 10 and 15 minutes of inhalation) and dlco (uncorrected) \<80% predicted. * female patients including those of childbearing potential will be included in this study. * negative pregnancy test at screening and baseline exclusion criteria: * fev1\<50% of predicted post-bronchodilator. * change in fvc (ml) \> ± 15% of screening value at baseline visit (not less than 14d after screening visit). * use of any medicine containing estrogen in the 4 months prior to the screening visit and for the duration of the study * significant hematologic, renal, hepatic laboratory abnormality or amylase \> 1.5x the upper limit of the normal range at the screening or baseline visits * fasting blood glucose \> 126mg/dl or random blood glucose \>200mg/dl at screening and/or baseline * recent surgery (involving entry into a body cavity or requiring sutures) within 2 months of the screening visit or any evidence of unhealed surgical wound. * uncontrolled hyperlipidemia (defined as persistent elevation of total cholesterol or triglycerides \>6.5nm/l) or a history of clinical atherosclerotic disease including heart attack, angina, peripheral vascular disease or stroke. * previous organ transplantation * inability to give informed consent * inability to perform pulmonary function or 6 minute walk tests and imaging assessments other protocol-defined inclusion/exclusion criteria may apply

Keywords: lymphangioleiomyomatosis, high resolution ct scan, chest x-ray, 6 minute walk test, pulse oximetry, renal mri, pikometer
comparison of depression interventions after acute coronary syndrome

Conditions: Acute Coronary Syndrome; Depression

Summary: patients will be consented and screened within 2 to 6 months of the index acs. patients who have elevated depression (bdi\>=15 or bdi\>=10 assessed twice over two week period) and who continue to meet all of the trial's eligibility criteria will be consented. through informed consent, both arms of the trial will be described with equipoise as to these approaches to postacs depression care. patients who consent to randomization will be enrolled in the treatment trial. the intervention phase will be 6 months, and hence the final outcome assessments will be performed approximately 9 months after the index acs. interim measures of depression will be obtained at 2 and 4 months post-enrollment. major adverse cardiac events and all-cause mortality will also be ascertained at 6 months post-enrollment. quality assurance by an independent medical event adjudication committee using prospective guidelines will be employed.


Eligibility criteria:
inclusion criteria: * hospitalized for acs defined as unstable angina or mi * bdi greater or equal to 10 and \< 15 2-6 months post-acs on each of 2 occasions, or bdi greater than 15 on one occasion * age at least 35 years * fluent in english or spanish * able to complete baseline assessment within 2-6 months of index acs event * able and willing to provide informed consent exclusion criteria: * presence of non-cardiac condition likely to terminate fatally within 1 year * inaccessibility for intervention or follow-up (e.g., plans to move from the area) * cognitive impairment * need for immediate psychiatric intervention (i.e., requiring hospitalization or psychiatric intervention within 72 hours) * suicidal ideation * major psychiatric co-morbidity (current or by history) including active psychosis, bipolar disorder, or overt personality disorder * active substance abuse or dependency * chronic renal failure (receiving chronic dialysis treatment, or estimated glomerular filtration rate"...\[egfr\] \< 30 ml/min/1.73 m2) or moderate/severe liver disease (e.g., esophageal varices, portal hypertension, encephalopathy, gi bleeding) * participation in another clinical trial for the treatment of depression.

Keywords: acute coronary syndrome depression satisfaction with care
dysregulated urea-synthesis at terminal uremia

Conditions: Urea Cycle Disorder; Uremia

Summary: this project will examine the dysregulation of the urea cycle in patients with terminal uremia using a validated method named "functional hepatic nitrogen clearance"


Eligibility criteria:
inclusion criteria: * age \> or equal to 18 years * chronic hemodialysis during 3 months * patients with functioning arteriovenous-fistula assigned to "center-hemodialysis" at "nyresygdomme, auh skejby" exclusion criteria: * active infection * conditions with vomiting or diarrhea * diabetes * active disease being treated with chemotherapy, radiationtherapy, biologic- or similar treatments. disease under observation can be included. * liver disease * vessels on the upper extremities not suited for cannulation * prednisolone treatment during the last 8 weeks * pregnancy * bmi \> or equal to 30 or \< or equal to 18 * physically or mentally condition that does not allow the project to be completed * language-difficulties that does not allow the project to be completed
evaluation of root migration distance after coronectomy of impacted third molars

Conditions: Impacted Tooth With Abnormal Positioning

Summary: the aims of this study were to investigate postoperative pain, edema, and trismus after coronectomy procedure, to assess the risk of endodontic lesion formation at sixth month, and to determine relationship of the root migration distance with age.

the roots of impacted lower third molars may be associated with the inferior alveolar nerve (ian). to mitigate this risk and reduce trauma to the patient, a conservative approach involving the removal of the problematic crown portion and leaving the root may be adopted. this clinical study was conducted between 2021-2022 years and was accordance with the helsinki declaration of 1975, as revised 2013. all subjects were informed about the study and clinical procedures and provided written consent the study included 73 patients aged between 18-55 years. these patients were divided into two age groups: the first group, consisting of patients aged 18-30. the second group, consisting of patients aged 31-55. the coronectomy was surgically performed. postoperative pain, swelling, and interincisal distance were evaluated based on age. pain was assessed using a 10 cm visual analog scale (vas) with patients providing ratings before the operation and on the 3rd and 7th postoperative days. the progresion of endodontic lesion was evaluated in 6 months after coronectomy. the distance of root migration achieved at 6 months after coronectomy was measured by independent examiner. calibrated panoramic radiographs were used to determine the level of migration. the statistical analysis of the data obtained in our study was performed using spss software the needed statistical analyses were used for comparison of the data. the levene test was used for comparison of the root migration distances in the age groups. the significance level was set at 0.05.

Eligibility criteria:
inclusion criteria: * the study focused on applying coronectomy, a more conservative approach, instead of extraction for mandibular third molars associated with the inferior alveolar nerve that were indicated for prosthetic, orthodontic, prophylactic purposes, or those causing pericoronitis * systemically health, * to maintain ideal oral hygiene, * absence of caries, pulpal and endodontic lesions in the impacted third molar indicated for extraction * no known allergies to any antibiotics, or no use or history of bisphosphonate medication * no use of tobacco or any illicit drugs by the patient. * not being pregnant exclusion criteria: * other conditions unlike abovementioned items.

Keywords: coronectomy of impacted third molar tooth